Clinical Trial: Evaluation of the Effect of Combined HIFU and RF Treatment on Skin Elasticity in Healthy Subjects: A Prospective Randomized Split-Face Controlled Trial with Cutometer as the Primary Endpoint (Japan)

Tokyo, Feb. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060725) titled 'Evaluation of the Effect of Combined HIFU and RF Treatment on Skin Elasticity in Healthy Subjects: A Prospective Randomized Split-Face Controlled Trial with Cutometer as the Primary Endpoint' on Feb. 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Tokyo Chuo Beauty Clinic (TCB), Umeda Osaka Ekimae Clinic

Condition: Condition - This study does not target any specific disease and is intended to evaluate skin elasticity in healthy subjects. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to objectively evaluate the effect of combined HIFU and RF treatment on skin elasticity in healthy subjects and to assess its efficacy as a preventive aesthetic intervention against skin aging. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Left and right facial sides will be randomized 1:1. Treatment side: Combined HIFU and RF therapy Control side: No treatment Interventions/Control_2 - Left and right facial sides will be randomized 1:1. Treatment side: Combined HIFU and RF therapy Control side: No treatment

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - ･Healthy subjects without clinically evident facial skin disease ･Ability to attend scheduled study visits ･Provision of written informed consent Key exclusion criteria - ･Pregnant, possibly pregnant, or breastfeeding individuals ･Individuals with active facial skin disease (infection, eczema, severe acne, etc.) ･Individuals who have undergone facial HIFU, RF, high-energy laser treatment, thread lift, or facial surgery within 6 months ･Individuals who have received injectable treatments affecting facial contour within 3 months ･Individuals judged inappropriate for participation by the principal investigator Target Size - 26

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 18 Day Date of IRB - 2026 Year 02 Month 19 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2026 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069451

Disclaimer: Curated by HT Syndication.